Infusion Pump System

ABSTRACT

An infusion pump system is described that increases patient comfort and convenience. The infusion pump system includes an infusion site interface that is releasably connected to an infusion pump body, and has no tubing associated between the infusion site interface and the pump body. The infusion pump body may include a carrier frame that may be adhered to the skin of a user.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.11/557,910 filed on Nov. 8, 2006, which claims the benefit of U.S.Provisional Application 60/734,382, filed Nov. 8, 2005, U.S. ProvisionalApplication 60/758,955, filed Jan. 13, 2006, and U.S. ProvisionalApplication 60/771,496, filed Feb. 8, 2006. The disclosures of the priorapplications are considered part of and are hereby incorporated in theirentirety by reference in the disclosure of this application.

TECHNICAL FIELD

This invention relates to infusion pump systems.

BACKGROUND

An infusion pump may be used to infuse fluids, medication, or nutrientsinto a patient's body or circulatory system. An infusion pump isgenerally used intravenously, although subcutaneous, arterial andepidural infusions are occasionally used. Infusion pumps can reliablyadminister fluids in ways that would be impractically expensive orunreliable if performed manually by nursing staff. For example, infusionpumps can administer 1 mL per hour injections (too small for a drip),injections every minute, injections with repeated boluses requested bythe patient up to the maximum number per hour allowed (e.g. inpatient-controlled analgesia), or fluids whose volumes vary by the timeof day.

As infusion pumps can also produce quite high but controlled pressures,the pumps can inject controlled amounts of fluids subcutaneously(beneath the skin), or epidurally (just within the surface of thecentral nervous system—a very popular local spinal anesthesia forchildbirth).

Conventional infusion pumps rely on disposable infusion sets to link thepump system to an infusion site. These sets generally have a length oftubing between both ends to accommodate the patient's changes to wearposition, pump maintenance and programming and to facilitate changing ofthe catheter system. As pump systems gradually reduce in size andcomplexity, the tubing becomes tangled as a result of its length makingthe pumps difficult to use and uncomfortable for the patient.

SUMMARY

A disconnectable, body-worn infusion pump system allows a moreconvenient attachment method for the user of a body-attached orbody-worn pump. The device described herein may adhere to the skin of awearer. The infusion pump system maintains a fluid path between thewearer and a pump. This path can be intermittently broken andre-established without replacement of the catheter within the body ofthe user.

An infusion pump system is described that includes an infusion siteinterface including a soft cannula for penetration of the skin when theinterface is installed, and a hub that rises above the upper surface ofthe interface when the interface is installed, wherein the infusion siteinterface lacks tubing above the upper surface of the interface, and aninfusion pump body, wherein the infusion pump body can be releasablyconnected to the infusion site interface to form a direct connectionbetween the infusion pump body and the infusion site interface.

The system may include an infusion site interface adhesively attached tothe infusion site on a body. The infusion site interface may include acarrier frame having an adhesive on the upper surface, enablingtemporary adhesion of the pump body to the upper surface of the carrierframe. The infusion site interface may include a carrier frame, whereinthe carrier frame is adhesively connected to a body near an infusionsite location, and the carrier frame is connected to the hub. Thecarrier frame may be connected to the hub via structural supportsbetween the hub and an outer frame. The carrier frame may include awebbing.

The system may include an adhesive on the pump body that enablestemporary adhesion of the pump body to another surface. The exit port ofthe infusion pump body may connect directly to an entry port on theinfusion site interface.

The pump body may releasably connect to the infusion site interfaceusing a locking mechanism on the hub of the infusion site interface, ormay releasably connect to the infusion site interface using a guide onthe hub of the infusion site interface, or may releasably connect to theinfusion site interface using the penetration of a pump body exit portthrough an infusion site interface septum. The pump body exit port mayinclude a needle.

The infusion pump body may include a control system. The infusion siteinterface may have no tubing external to the skin of a user afterinstallation of the infusion site interface.

A method of operating an infusion pump system is described that includesdispensing medicament from a medicament reservoir in a pump body througha pump body exit port into an infusion site interface, wherein there isa direct connection between the infusion pump body and the infusion siteinterface during the dispensing, and wherein the pump body is releasablyconnected to the infusion site interface.

The pump body exit port may include a catheter that penetrates a septumof the infusion site interface. The catheter may include a needle. Thepump body exit port may connect directly to an entry port on theinfusion site interface. The pump body may releasably connect to theinfusion site interface using a locking mechanism, or may releasablyconnect to the infusion site interface using a guide on the infusionsite interface, or may releasably connect to the infusion site interfaceusing only the penetration of the pump body exit port through aninfusion site interface septum.

The infusion site interface may be adhesively attached to the infusionsite on a body. The pump body may be adhesively attached near theinfusion site. The pump body may be adhesively attached to an uppersurface of the infusion site interface. The pump body may be adhesivelyattached using a single layer adhesive.

An infusion pump system is described that includes an infusion siteinterface including a soft cannula for penetration of the skin when theinterface is installed, a carrier frame that can be adhesively attachedto a body surface, and a hub that is connected to the carrier frame andrises above the carrier frame when the interface is installed, and aninfusion pump body, wherein the infusion pump body can be connected,detached, and re-connected to the infusion site interface as desired toform a direct connection between the infusion pump body and the infusionsite interface.

An infusion pump system is described that includes an infusion siteinterface including a soft cannula for penetration of the skin when theinterface is installed, a carrier frame that can be adhesively attachedto a body surface, and a hub that is connected to the carrier frame andrises above the carrier frame when the interface is installed, and aninfusion pump body that can be releasably connected to the infusion siteinterface, forming a direct connection between the infusion pump bodyand the infusion site interface, and an adhesive surface on the infusionpump body.

The adhesive surface may be used to attach the infusion pump body to theinfusion site interface. The adhesive surface may be used to attach theinfusion pump body near an infusion site.

As used herein, the term “direct connection” refers to a connection thatdoes not include any tubing or similar intermediary between the twoendpoints of the direct connection.

As used herein, the term “medicament” generally refers to all fluids,medication, drugs, nutrients, biomaterials, chemicals, or othermaterials that may be dispensed by an infusion pump.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is an illustration of an assembled and connected infusion pumpsystem attached to a human torso.

FIG. 2 is an illustration of an example of an infusion pump system,including an infusion pump body detached from an infusion siteinterface.

FIG. 3 is a cross-sectional illustration of an assembled and connectedinfusion pump system.

FIG. 4 shows an assembled view of one example of an infusion siteinterface.

FIG. 5 shows a component view of one example of an infusion siteinterface.

FIG. 6 is an illustration of one example of an infusion site interface.

FIG. 7 is a cross-section view of the infusion site interface shown inFIG. 6.

FIG. 8 is a top view illustration of another example of an infusion siteinterface.

FIG. 9A is an illustration of another example of an infusion siteinterface having an access port.

FIG. 9B is an illustration of another example of an infusion siteinterface having an access port and a septum.

FIG. 10 is an illustration of another example of an infusion siteinterface.

FIG. 11 is an illustration of another example of an infusion siteinterface.

FIG. 12A illustrates an infusion pump system 1200 which may be used withan infusion site interface such as the ones shown in FIG. 6.

FIGS. 12B-D are illustrations of examples of infusion pump systems withadhesives for affixing near an infusion site.

FIGS. 13A-C are illustrations depicting steps of one method that can beused to attach an infusion pump system to an infusion site interface.

FIGS. 13D-F are illustrations depicting steps of one method that can beused to attach an infusion pump system to an infusion site system.

FIG. 14 depicts an alternate embodiment of an infusion pump system 1400with a flexible neck for use with an infusion site interface.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

An infusion pump system is described that increases patient comfort andconvenience. The infusion pump system includes an infusion pump body andan infusion site interface. The infusion pump body is releasablyconnected to the infusion site interface, and therefore there is noassociated tubing between the infusion pump body and the infusion siteinterface. The infusion pump body also includes a housing that may beadhered to the skin of a user.

FIG. 1 shows a view of an assembled infusion pump system 100 attached toa human torso. The infusion pump system 100 may be used to infuse amedicament directly into an infusion site. A complete flow path isformed from a medicament reservoir within the infusion pump system 100to the infusion site.

FIGS. 2-3 are illustrations of a self-contained infusion pump systemincluding an infusion site interface. FIG. 2 shows a disassembled viewof the infusion pump system 100, including a pump body 102 and aninfusion site interface 104. FIG. 3 shows a cut-away cross-section viewof the assembled infusion pump system 100. The component partsillustrated in these views create a complete, self contained medicineinfusion pump system when assembled.

Returning to FIG. 2, the infusion pump body has an upper housing 111 anda lower housing 112 which define a periphery in which the pumpmechanisms reside. The lower housing 112 may be adhered to a user's skinby means of an adhesive system. The upper and lower housings 111, 112may include openings or penetrations 114 for attachment and guidance ofthe infusion site interface 104 to the pump body 102. Additionally, theopenings 114 may allow for installation of a reservoir contained withinthe pump body 102. One or more buttons 113 may be used to enter userrequests into the pump system.

As can be seen in FIG. 3, mechanisms that are contained in the pump body102 may include a reservoir 118, a drive mechanism 124, and a controlsystem. The reservoir 118 includes a distal end 128 and a proximal end130. The reservoir 118 may be cylindrical in geometry with the distalend 128 sealed by a moveable plunger 131 of matching geometry as thereservoir 118. The proximal end 130 of the reservoir 118 may be closedby a reservoir septum 132. In some embodiments, the reservoir septum 132may be formed of a self-sealing material, such as silicone or rubber. Inother embodiments the proximal end 130 of the reservoir 118 may beclosed by a valve or other device. The drive mechanism 124 may beactuated to apply pressure internal to the reservoir so that amedicament contained within the reservoir 118 may be dispensed out ofthe reservoir 118. In one embodiment, the medicament may be pushedthrough a device that pierces the reservoir septum 132. In otherembodiments, the medicament may be pushed through a valve or otherdevice at the proximal end 130 of the reservoir 118. The actuation ofthe drive mechanism 124 may be governed by the control mechanism. Thegeometry of the reservoir 118 has been shown as cylindrical forillustrative purposes only and the reservoir 118 is geometryindependent.

In one embodiment, a reservoir 118 containing a medicament may beinstalled in the pump body 102 via an opening in the pump body 114. Theinfusion pump body may be prepared for use after installation of theinfusion site interface 104 at a body location. In some embodiments, theinfusion pump body may be prepared for use by inserting a reservoir 118of medicament in the infusion pump body 102. For example, a generallycylindrical and geometrically matched medicament reservoir 118 isinserted into the vacant pump cavity. In another embodiment, thereservoir might be installed by separating the pump body, such as byseparating upper and lower housings. In another embodiment, thereservoir might be pre-loaded into the pump body, and require no userloading. Examples of medicaments that may be contained in the medicamentreservoir 188 may include insulin, pain relief drugs, hormone therapy,blood pressure treatments, anti-emetics, osteoporosis treatments, orother injectable medicines or liquids.

FIGS. 4 and 5 show assembled and component views of one example of aninfusion site interface 104. The infusion site interface may also bereferred to as a catheter head system. The infusion site interface 104provides for continuous or intermittent subcutaneous fluid infusion andis comprised of an upper housing 140, a lower housing 142, a hub 144having a hollow chamber, an infusion site interface septum 146, acatheter of biocompatible material 149, and an O-ring 152 for sealingthe exterior surface 155 of the hub 144 against the interior surface ofthe pump body 102 associated with the opening 114 of the pump body. Thecatheter 149 may be used for indwelling in a user after installation ofthe infusion site interface 104 at a location on the body. The catheter149 also defines a through passage for passing a medicament from theinfusion pump system into a body. The infusion site interface 104provides for the continuous fluid path between the reservoir 118 and theuser.

A continuous fluid path may be formed by connecting one side of the hub144 to the pump body. One side of the hub 144 may be equipped with aseptum piercing device 162 that penetrates the reservoir septum 132(shown in FIG. 3), enabling medicament to enter the hub. In oneembodiment, the medicament may enter a chamber or junction within thehub 144. Medicament may flow from the hub 144 through the catheter 149and into the user. Typically, the infusion site interface 104 isequipped on a side generally tangent to the septum piercing device 162and coplanar to a user's skin. The biocompatible catheter 149 may beused for subcutaneous infusion of medicine to a user. Thus, the septumpiercing device 162 of the infusion site interface 104 may initiate apathway for medicament by penetration of the reservoir septum 132 duringattachment of the pump body 102 to the infusion site interface 104.During treatment, medicament may traverse from the reservoir 118 throughthe septum piercing device 162, through the hub 144 and catheter 149,and into the user.

Referring again to FIG. 2, the infusion site interface 104 may beattached to the pump system 102 by insertion of the generallycylindrical exterior surface 155 of the hub 144 of the catheter headsystem 104 into the geometrically matched opening 114 of the pump body102. In some embodiments, the exterior surface of infusion siteinterface 104 may contain alignment features of geometry such that theinfusion site interface 104 may be attached in a single orientation ordiscreet set of orientations into matching mating features in the pumpbody 102. The alignment feature(s) on the exterior surface of the hub144 may allow the infusion site interface 104 to be securely attached tothe pump body 102, preventing unintended separation of the two systems.

In another embodiment, the pump system 102 may attach to the infusionsite interface 104 using another method or device which allows for thesecure attachment of the infusion site interface 104 to the pump body102. In one approach, the secure attachment may be in the form of alocking ring which securely and releasably locks the infusion siteinterface 104 to the pump system 102. In another approach, the secureattachment may be in the form of a Luer-lock connection. In anotherapproach, the secure attachment may be created by a mechanism or methodwhich is detachable from the completed system, such as flexibleconnector. In another approach, the secure attachment may be in the formof replaceable locking tabs on the upper housing 111, the lower housing112 or infusion site interface 104. When locked, the tabs on theinfusion site interface 104 may engage features on the pump body 102 toprevent the accidental release of the infusion site interface 104.Alternatively, locking tabs on the pump body 102 may engage features onthe infusion site interface 104 to prevent accidental releases. Theinfusion pump body may be directly connected to the infusion siteinterface, such that there is no tubing or other intermediate betweenthe pump body and the infusion site interface.

FIG. 6 shows one example of an infusion site interface 600. FIG. 7 showsa cross-section view of the infusion site interface 600 shown in FIG. 6.

The infusion site interface 600 includes a soft cannula 602 ofbiocompatible material that may be inserted into the body of a user. Thecannula 602 is attached at its upper or proximal end to an annularsealing flange 607 that forms the center of a carrier frame 640. Thecannula 602 also defines a central channel 620. The annular sealingflange 607 may be attached coaxially to the lower or distal surface ofan inner ring or hub 614. Together, these elements provide for thecreation of a continuous fluid flow path from the orifice of the hub 614through to the cannula 602. These elements may also form the confines ofan intermediate chamber in the hub 614 that connects to the channel 320in the cannula 602. The hub 614 defines a central orifice that may beclosed by a septum 630 that seals the fluid path of the hub 614 andcannula 602 from the outside world.

The infusion site interface 600 may also include a carrier frame 640.The carrier frame 640 may include as components an outer frame member621 and one or more structural supports 624. The outer frame 621 may beattached to the hub 614 by one or more structural supports 624. Thestructural supports 624 may be configured to be radial spokes, curvedsupporting members, or other configurations. In various embodiments,there may be zero, one, or multiple structural supports 624. Thecomponents forming the carrier frame 640 may be made of a rigid,semi-rigid, or flexible material which may be adhered to the body by askin adhesive system. The carrier frame may also include a flexible meshor other material between the hub 614, outer frame member 621 andstructural supports 624. When present, the flexible mesh or othermaterial may improve the adhesion of the infusion site interface 600 toa treatment location on a body. The flexible mesh may also assist inattaching, detaching, or handling the infusion site interface 600.

The outer frame member 621 may be of size and shape to permit convenientplacement on the body. The outer frame member 621 may be of sufficientrigidity to maintain secure location of the cannula 602 in the body ofthe wearer, and act to prevent the infusion site interface 600 fromchanging position or detaching from the desired location. The outerframe member 621 may be of sufficient flexibility to maintain wearercomfort, and maintain attachment of the cannula to the wearer during thenormal wear duration.

The cannula 602 may be a biocompatible plastic tube insertedsubcutaneously in the body of the wearer to create a fluid path from apump device to a location within the body of the wearer. The cannula 602may be rigidly or flexibly attached to the hub 614 of the frame.Generally, the cannula 602 is maintained at a location within the bodyof the wearer by the adhesion of the carrier frame of the adhesion siteinterface 600 to the body of the wearer. The infusion site interface maybe designed such that there is no tubing that extends external of thebody after the infusion site interface is in place. Thus, the infusionsite interface may be located on a surface of a body, with a softcannula descending to a tissue location. The infusion site interface mayalso include a carrier frame that is adhesively attached to the body,holding the infusion site interface in place, and a hub that extendsabove the surface of the of the carrier frame for attachment of a pumpbody.

The septum 630 provides a penetrable barrier or seal from the insertedcannula 602 to the outside world. The septum 630 may be of a sizesufficient to allow the insertion of a drug delivery needle (asdescribed below) or a similar drug delivery conduit. The entry of thedrug delivery conduit into the cannula 602 may be perpendicular to theskin surface or at a suitably convenient angle. The septum 630 may beformed of a self-sealing material such as rubber or silicone.

The infusion site interface 600 may also include a leak detectionmechanism, whereby positive indication is provided to the wearer of theinfusion site system 600 that a compromise in the fluid path hasoccurred. This indication can be by visual or tactile means eitherthrough color change or a means for dermal stimulation at the site.

FIG. 8 shows a top view of one embodiment of an infusion site interface800. The infusion site interface 800 shown is similar to infusion siteinterface 600 in FIGS. 6 and 7, with the exception that the hub 814 isattached to the outer frame member 821 by a plurality of structuralsupports 824 that are curved radial spokes. In some embodiments, thecarrier frame may also include a flexible mesh or other material betweenthe hub 814, outer frame member 821 and structural supports 824.

FIG. 9A shows another example of an embodiment of an infusion siteinterface 900. The infusion site interface 900 includes a central hub904 and a cannula 902. The cannula 902 may be formed of a softbiocompatible material, and is designed for insertion into the body of auser. The central hub 904 includes an access port 917 and lockingfeatures 921. The access port 917 connects to the cannula 902 such thatmedicaments that pass through the access port 917 pass through and intothe cannula 902 for infusion into a user. The locking features 921 maybe used to affix an infusion pump body to the infusion site Interface. Acovering which normally seals against the access port 917 to preventforeign materials from entering the infusion site system 900 opens whenan infusion pump body is attached to allow medicaments pumped from theinfusion pump body to pass into the infusion site interface.

The infusion site interface 900 may also include a carrier frame 907.The carrier frame 907 may include an outer frame member 908 and aflexible material 911.

The central hub 904 may be connected to the outer frame member 908 bythe flexible material 911. The flexible material 911 may be formed of amesh or other material. The carrier frame 907 formed by the outer framemember 908 and flexible material 911 may adhere to the body by aconventional adhesive system.

FIG. 9B shows another example embodiment of an infusion site interface950, similar to the infusion site interface of FIG. 9A. The infusionsite interface 950 shown in FIG. 9B also includes a septum 975 locatedon the top surface of the hub 954. In this embodiment, the access port967 or the septum 975 may be used to supply a medicament from aninfusion pump body to the cannula 952 for infusion into a user.

FIG. 10 shows another example embodiment of an infusion site interface1000. Infusion site interface 1000 includes a hub 1004 and a carrierframe 1005. The carrier frame 1005 includes an outer frame member 1008and a flexible mesh 1006. The outer frame member 1008 is affixed to thehub 1004 by the flexible mesh 1006. The carrier frame 1008 may be in arectangular shape, as shown in FIG. 10, or may have alternate shapes,such as a circle, square, or ellipse, or may have other regular orirregular shapes. Adhesive may be applied to the bottom surface of thecarrier frame, including the flexible mesh 1006 and the outer frame1008, and may be used to affix the infusion site system to a user'sbody.

The hub 1004 includes an access port 1017, a septum 1025, and lockingfeatures 1021. The locking features 1021 may be used to affix aninfusion pump system to the infusion site system 1000. The access port1017 and septum 1025 connect to a cannula (not shown) such thatmedicaments from an infusion pump body which pass through the accessport 1017 or septum 1025 pass through and into the cannula for infusioninto a user.

FIG. 11 shows another example embodiment of an infusion site interface1100. Infusion site interface 1100 includes a cannula 1103, a centralbody hub 1105, and a carrier frame 1113. The cannula 1103 is attached tothe central body hub 1105, and may be accessed by an infusion pump bodyvia a septum 1106. A locking mechanism 1107 may be incorporated into thecentral body hub 1105 and may be used to attach an infusion pump body tothe infusion site interface 1100. The carrier frame 1113 may include anouter frame member 1008 which is connected to the central body hub 1105by a structural support 1115. In this embodiment, the structural supportis configured as webbing. The webbing may be rigid, semi-rigid, orflexible. In some embodiments, the carrier frame 1113 may also include aflexible mesh or other material between the central body hub 1105, outerframe member 1008, and webbing 1115. The carrier frame 1113 may beadhered to a user's body via the outer frame member 1117, webbing 1115,and if present, the optional mesh or other material. In otherembodiments, the central body hub 1105 may have one or more guidingmembers to guide an infusion pump body for attachment to the infusionpump interface 1100.

The skin adhesive system used with the infusion site systems describedabove may include a variety of systems, methods, and materials. In oneembodiment, the skin adhesive system may be a flexible membrane withskin compatible adhesive capable of removably securing an infusion siteinterface to the skin of a user. In another embodiment, a flexiblemembrane may have a skin compatible adhesive on a first surface and adevice compatible adhesive on a second surface. In other embodiments,the skin adhesive system may include an adhesive composed of a singlelayer material that is adhesive to both the user's skin surface and theinfusion site interface. Variously, the adhesive material may be a gellayer, a liquid layer that dries after contact, or other material. Theprecise size and placement of adhesive may be dependant on theapplication. Typically, the adhesion of the infusion site interface to auser's skin may also include adhesion of a carrier frame to the user'sskin.

FIGS. 12A-12D illustrate how adhesives may be used with an infusion pumpbody 1200 to establish a fluid path from the infusion pump system 1200to an infusion site system without direct mechanical coupling, therebycreating a “floating” fit wherein the flexibility of the infusion pumpsystem including the infusion pump body and the infusion site interfaceis greatly increased.

FIG. 12A illustrates an infusion pump body 1200 which may be used withvarious infusion site interfaces, such as the ones shown in FIG. 6. Theinfusion pump body 1200 includes a casing 1210 which contains areservoir and pumping mechanism. The infusion body 1200 also includes aninfusion site docking area 1212 with a septum piercing device 1220 thatmay provide a direct fluid path from the reservoir to the infusion siteinterface. The septum piercing device 1220 also serves as the exit portof the infusion pump body. The pumping mechanism including the pumphousing 1210 may cause a medicament in the reservoir to flow through theseptum piercing device 1220 and pass into an infusion site interface.

A connection between the infusion pump body and an infusion siteinterface may be created by the septum piercing device penetrating aseptum of the infusion site interface. This may be accomplished withoutthe direct attachment of the infusion pump housing 1210 to the infusionpump interface. The infusion pump body would then be able to moverelative to the infusion site interface, and move as the user moved. Theinfusion pump body may use manual or automatic methods to establish thefluid connection after placement of the infusion pump system 1200 on thebody. In some embodiments the infusion site interface and the infusionsite docking area 1212 may include corresponding guiding members, suchthat the pump casing 1210 may be guided onto the infusion siteinterface. This embodiment would allow for vertical flexibility, whilerestricting horizontal motion between the pump body 1200 and theinfusion site interface.

The adhesive system described above may be sufficient size andcapability to adhere the infusion site interface to the skin of theuser. In some embodiments, the adhesive system may also have sufficientsize and capability to also adhere the infusion pump body to the skin ofthe wearer or to the infusion site interface. A release liner may beused with the adhesive system. Prior to application of an adhesive, arelease liner may cover exposed adhesives to prevent unintentionaladhesion. Immediately before or during application, the release linermay be removed to expose the adhesive layer for use.

FIG. 12B shows one embodiment of an adhesive system. In this adhesivesystem, the adhesive 1240 covers a portion of the bottom of the infusionpump body 1200.

FIG. 12C shows another embodiment of an adhesive system, in whichadhesive 1250 covers the entire bottom of the infusion pump body 1200.

FIG. 12D shows another embodiment of an adhesive system, in whichadhesive 1260 extends past the edges of the infusion pump system 1200.

In some embodiments, the adhesive may be formed as a planar substrate ofmaterial to which adhesive may be applied to one or both sides. A firstadhesive, such as hydrocolloid or synthetic rubber, may be applied tothe skin contacting surface for extended adhesion to human skin in allconditions. A second adhesive, such as acrylic, synthetic rubber or anyother type of adhesive that is appropriate for the characteristics ofthe adhesive system, may be applied to the device contacting surface. Insome embodiments, the adhesive system may include a flexible agent witha skin compatible adhesive on a first surface and a device compatibleadhesive on a second surface.

The variation in thickness of the carrier across the surface of adhesionis dependant on the material selected for the carrier and the mechanicalproperties desired. In some embodiments, the carrier thickness will bein the range of 0.1 mm to 1 mm. For example, a carrier frame includingan adhesive patch designed to extend 2.5 cm from the periphery of aninfusion site hub may, for example, have an adhesive thickness of 0.5 mmat region of contact with the infusion site interface hub, and athickness that decreases to a thickness of 0.2 mm at the edges. In someembodiments, the carrier frame of an infusion site interface may bedesigned to stretch, allowing greater comfort for the user and betteradhesion for the device. Both linear and non-linear adhesive thicknesschanges are possible.

In some embodiments, a single adhesive layer or coating may be applieddirectly to skin-contacting surfaces of the infusion pump body. Suitableadhesives include hydrocolloid, acrylic, synthetic rubber or other typeof adhesive that is appropriate for the characteristics of the deviceand user skin.

In various embodiments, the adhesive system may also include compoundsto reduce or modify the discomfort associated with attachment of theinfusion site interface, or the pump body to the skin. These compoundsinclude, but are not limited to, compounds intended to reduceirritation, inflammation and itching. The compounds may be included inthe manufacture of the adhesive or the carrier material, or subsequentlyan adhesive that is manufactured with these properties specificallyintegrated into the chemical composition may be applied to the deviceafter manufacturing.

FIGS. 13A-C depict an example of an infusion pump body 1300 with alocking attachment mechanism being attached to the infusion siteinterface 1000. In FIG. 13A, the infusion pump body 1300 is aligned witha locking collar in the infusion pump body 1300 such that lockingfeatures 1021 match up with corresponding features in the lockingcollar. Pressing the infusion pump system down onto the infusion sitesystem causes a septum piercing device to pierce the septum 1025. Insome embodiments, the attachment mechanism connecting the infusion pumpbody 1300 to the infusion site interface 1000 may be a Luer lock.

FIG. 13B shows a twisting motion used to lock the infusion pump body1300 onto the infusion site interface 1000. FIG. 13C shows the completeinfusion pump system including the infusion pump body 1300 locked to theinfusion site interface 1000 via the locking features 1021. In someembodiments, the infusion site interface 1000 includes an adhesive onthe top surface of the infusion site interface. In such a case, the pumpbody 1300 would also be adhesively attached to the infusion siteinterface, creating a tighter connection between the components of theinfusion pump system. In other embodiments, the top surface of theinfusion site interface 1000 and the bottom surface of the infusion pumpbody 1300 may include a mechanical adhesion system. In such a system,the pump body 1300 would be mechanically adhered to the infusion siteinterface 1000, also creating a tighter connection. An example of amechanical adhesion system that may be used includes a Velcro adhesivesystem, or other mechanical adhesion.

FIGS. 13D-E depict another example of an infusion pump body 1300 with alocking attachment mechanism being attached to the infusion siteinterface 1000. Similar steps to FIGS. 13A-C are shown, with a differentinfusion site interface. In this example, infusion site interface 900 isused to affix the infusion pump body 1300 to the user's body. Inaddition, an additional mesh 1305 is used to secure the infusion pumpbody 1300 to the user's body after attachment to the infusion siteinterface. In various embodiments, the additional mesh 1305 may includean adhesive on the top surface for attachment to the pump body 1300, ormay include a mechanical adhesion system used in conjunction with othercomponents on the infusion pump body 1300.

In some embodiments, an infusion pump system may be attached to aninfusion site system with an insert and twist method, or alternately adetent fit or user activated locking lever or securing mechanism wherebythe frame of the infusion site system is mechanically coupled to thebody of the infusion pump system.

In other embodiments, the alignment method may use guide features toconnect a pump body with an infusion site interface. These guidefeatures may employ geometries or shapes for the infusion site interfacein which complimentary geometries and shapes are provided on theinfusion pump body to maintain alignment.

In other embodiments, the mechanical attachment of infusion pump body tothe infusion site interface 600 may be effected without mechanicallocking. The infusion site interface may include a mechanism for thealignment of the infusion pump body, with adhesion of the pump body tothe skin being the only method employed to retain the exit port of theinfusion pump body within the infusion site interface to maintain fluidpath continuity.

FIG. 14 depicts an alternate embodiment of an infusion pump body for usewith an infusion site system. The infusion pump body 1400 includes apump body reservoir section 1410, a flexible neck 1414, and an infusionpump head 1412. The infusion pump head 1412 is used to connect to aninfusion site interface, such as those described earlier. The flexibleneck 1414 allows the pump body 1410 and infusion site interface to movesemi-independently relative to each other when attached together. Thepump body reservoir section 1410 includes a pumping mechanism 1420 and areservoir 1430 containing a medicament to be infused. The reservoir 1430is connected to an exit port 1431 on the infusion pump head 1412 suchthat a medicament in the reservoir may flow directly from the reservoirto an attached infusion site interface. The exit port 1431 may be formedof a septum piercing device.

In some embodiments, the infusion pump body 1400 may have a window 1421which may be used to access the infusion site. Such a window may allowfor inspection or care of the infusion site without removing theinfusion pump body 1400. In some embodiments, the window 1421 may beable to be opened or moved aside, allowing for access to the infusionsite or infusion site interface. For example, this might allow forinjection of an additional or different medicament using the sameinfusion site interface.

While several specific embodiments and variations have been describedherein, it will be appreciated that other variations and modificationsmay be encompassed within the scope of the present invention, and thatstructural and functional equivalents to the various components andstructures described herein will occur to those skilled in the pertinentarts. For example, the physical shape and size of the individualcomponent parts, as described herein, are exemplary only, and othershapes and configurations will readily suggest themselves. Likewise,various ways may be found to attach the infusion site system to the pumpand or to provide a separate locking mechanism. Furthermore, theconfigurations of the mechanisms and elements described herein arelikewise exemplary only. The extent of this document should be deemed toinclude any device that exemplifies the concepts described herein andthese and other variations and modifications that may suggest themselvesto those skilled in the pertinent arts are considered to be within thespirit and scope of the present invention. Accordingly, otherembodiments are within the scope of the following claims.

1. A method of operating an infusion pump system, comprising: dispensingmedicament into a user's body from a medicament reservoir in an infusionpump body through a pump body exit port into an infusion site interfacecoupled to the user's body, wherein there is a direct connection betweenthe infusion pump body and the infusion site interface during thedispensing of the medicament into the user's body, and wherein the pumpbody is releasably connected to the infusion site interface during thedispensing of the medicament into the user's body, disconnecting theinfusion pump body from the infusion site interface to ceasedispensation of the medicament to the user's body.
 2. The method ofclaim 1, wherein the pump body exit port comprises a catheter thatpenetrates a septum of the infusion site interface.
 3. The method ofclaim 2, wherein the catheter comprises a needle.
 4. The method of claim1, wherein the pump body exit port connects directly to an entry port onthe infusion site interface.
 5. The method of claim 1, wherein the pumpbody releasably connects to the infusion site interface using a lockingmechanism.
 6. The method of claim 1, wherein the pump body releasablyconnects to the infusion site interface using a guide on the infusionsite interface.
 7. The method of claim 1, wherein the pump bodyreleasably connects to the infusion site interface using only thepenetration of the pump body exit port through an infusion siteinterface septum.
 8. The method of claim 1, wherein the infusion siteinterface is adhesively attached to the infusion site on a body.
 9. Themethod of claim 1, wherein the pump body is adhesively attached to theuser's body near the infusion site interface.
 10. The method of claim 1,wherein the pump body is adhesively attached to an upper surface of theinfusion site interface.
 11. The method of claim 1, wherein the pumpbody is adhesively attached using a single layer adhesive.
 12. A methodof operating an infusion pump system, comprising: adhering an infusionsite interface structure to a skin surface, the infusion site interfacestructure comprising: a frame with a lower surface facing toward theskin surface and an upward facing surface that is opposite the lowersurface, a soft cannula coupled to the frame and extending below thelower surface of the frame for insertion subcutaneously through the skinsurface to at least partially define a fluid path, and a septum arrangedin the fluid path and coupled to the frame in a position above theupward facing surface of the frame; and releasably connecting aninfusion pump device to the frame of the infusion site interfacestructure adhered to the skin such that the infusion pump device ismechanically coupled to the frame of the infusion site interfacestructure and a piercing member of the infusion pump device penetratesthe septum of the infusion site interface to define the fluid path froma medicine reservoir housed in the infusion pump device, through thepenetrated septum of the infusion site interface structure, and throughthe soft cannula inserted subcutaneously through the skin surface;causing the infusion pump device to dispense medicine into a user's bodyvia the fluid path from the medicine reservoir housed in the infusionpump device, through the penetrated septum of the infusion siteinterface structure, and through the soft cannula insertedsubcutaneously through the skin surface; disconnecting and reconnectingthe infusion pump device to the infusion site interface structure sothat the fluid path is broken and re-established without replacement ofthe infusion site interface structure.
 13. The method of claim 12,wherein the step of releasably connecting the infusion pump device tothe frame of the infusion site interface structure comprises forming adirect connection between the infusion pump device and the infusion siteinterface structure such that the fluid path is free of tubing.
 14. Themethod of claim 12, wherein the step of releasably connecting aninfusion pump device to the frame of the infusion site interfacestructure comprises positioning the infusion pump device over the upwardfacing surface of the frame of the infusion site interface.
 15. Themethod of claim 12, wherein the piercing member of the infusion pumpdevice comprises a needle that penetrates the septum of the infusionsite interface structure.
 16. The method of claim 15, wherein the needleof the infusion pump device extends downwardly through an upper face ofthe septum such that the needle extends generally perpendicular to theskin surface when the needle penetrates the septum of the infusion siteinterface structure.
 17. The method of claim 16, wherein the frame ofthe infusion site interface structure comprises an inner ring hub thatcarries the septum and an outer wall that is spaced apart from the innerring hub and surrounds the inner ring hub.
 18. The method of claim 17,wherein the soft cannula is rigidly attached to the inner ring hub ofthe frame of the infusion site interface structure.
 19. The method ofclaim 18, wherein during the step of releasably connecting an infusionpump device to the frame of the infusion site interface structure, theneedle of the infusion pump device is aligned with the inner ring hub ofthe frame of the infusion site interface structure.
 20. The method ofclaim 12, wherein the step of disconnecting and reconnecting theinfusion pump device to the infusion site interface structure comprisestemporarily detaching the infusion pump device from the infusion siteinterface structure while the infusion site interface structure ismaintained on the skin surface.
 21. The method of claim 12, wherein theinfusion pump device is mechanically coupled to the frame of theinfusion site interface structure using a detent fit.
 22. The method ofclaim 12, wherein the infusion pump device is mechanically coupled tothe frame of the infusion site interface structure using aninsert-and-rotate fit.
 23. The method of claim 12, further comprisingusing a leak detection mechanism of the infusion pump system for adetermination that the fluid path is compromised by a leak.